Will The FDA Ever Get Over Its Hemo-phobia? Ctd

A gay physician writes in:

Your reader estimates that under new FDA rules there might be two additional cases of HIV infection each year – and then concludes that this “unacceptable.” But where was the calculation of how many lives might be saved because of the new available blood? An entire side of the equation is missing.

Almost every decision in medicine involves judging risks versus benefits. Your reader appears to feel that for blood transfusions, our overriding principle must be that the “risk of giving a patient contaminated blood is as low as humanly possible.” That would make sense if every hospital in the country was replete with usable donated blood. However, last time I checked, the Red Cross was describing an “urgent need” for more donations.

A vivid recollection from my intern year: a middle-aged man with cirrhosis in the intensive care unit suddenly ex-sanguinating from his GI tract at two o’clock in the morning. He likely would have died without massive blood transfusions. In that moment, the benefit of having available blood clearly outweighed any minuscule risk of contracting HIV.

Another expert weighs in:

I have written about biomedical research and policy for more than two decades. Even accepting that your writer’s assumptions and math are correct, what the comment lacks is a context.

Blood transfusion, like life, does carry risk. The FDA reports that 65 people died from blood transfusions in 2013. Often human error is a significant factor in those deaths. About 2-3 HIV infections occur each year in the US through blood transfusions, and that might increase by 1-2 if the policy is changed. But other serious and often fatal infections – sepsis, Hepatitis B, Hepatitis C, West Nile Virus – also are transmitted through transfusion, and at significantly higher rates. More about that issue here.

Additionally, a true risk/benefit calculation would have to factor in the impact of not having blood, particularly rare types, available for trauma victims and surgery. While the cost may be small, as with HIV transmission, it does exist. The discriminatory policy has negatively affected the ability to collect blood on college campuses. A growing body of research points to “young” blood as being more beneficial than that of an older person.

The experts who deal with transfusion medicine on a daily basis have studied these issues for many years and have concluded that lifting the gay blood ban is more cost-effective to society than keeping it in place. I trust their judgment more than I do that of some reader who cherry-picks issues and makes back-of-the-envelope calculations.

Another piles on:

Your reader argues that two additional deaths per year “simply for going to the hospital” is an unacceptably high risk. He might be alarmed to know that, according to CDC estimates, 1 in 25 patients who simply walk into a hospital will contract an infection during the course of their stay, adding up to 722,000 infections in 2011. About 75,000 patients with such health care associated infections die while in the hospital, although the presumably some of the patients might have died anyway. Perhaps we should ban hospitals? Or perhaps we should weigh benefits in addition to risks.

And another:

The math this reader laid out completely ignores the entire social context of this issue. The problem here is that the guidelines assume there is no way to make distinctions between gay men when it comes to risk of blood-bourne illnesses. If you start from the presumption that there is no screening technique that could possibly give a more accurate picture than “any gay man who has had any sex in the last year is a potential disease vector,” then sure, that math makes sense. By the same token, this map notes high incidence of HIV diagnosis (at least 428 per 100,000) among residents of NY, CT, NJ, DE, MD, DC, FL, SC, GA, and LA. That’s almost a quarter of the US population. In the absence of a ban on the residents of these states giving blood, we can assume (by the same very rough math used by that reader) that about 0.1% of donated blood is HIV positive. The reason we don’t ban entire states from donating blood is that there are very simple questions we can ask that are only tangentially related to their place of residence which much more efficiently assess risk.

One more reader zooms out:

I think that one of the really wonderful things about the gay rights movement at this point in time is that the world is sort of opening up so quickly that everyone can be somewhat patient, and have faith in the progress to come. It’s not necessary to dig in, and it’s easier not to get angry. Your debate about the FDA guidelines is a great example. If there is a bias in the blood donation policy, we can sort of unpack it and think about it clearly. I think it’s a pretty unusual place to be in a struggle for civil rights.